Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R Recalled by Smiths Medical ASD Inc. Due to Specific lots of Medex High Pressure Adaptors, Rotators,...

Date: March 31, 2021
Company: Smiths Medical ASD Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Smiths Medical ASD Inc. directly.

Affected Products

Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer.

Quantity: 500 units

Why Was This Recalled?

Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Smiths Medical ASD Inc.

Smiths Medical ASD Inc. has 169 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report